Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics

Pain Clinical Trial

— IGNITE  

Official title:

Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335307
• Other study ID #: IRB201400501 - N
• Secondary ID: U01HG007269-02OC
• Status: Completed
• Start date: June 2015
• Est. completion date: October 25, 2017

Study information

• Verified date: June 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will examine the effect of having genotype information on pain management and pain control for patients treated in family medicine clinics. This study will also examine physician-perceived usefulness of genotype information. Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites. Patients from implementation sites will undergo genotyping, while those from control sites will not by genotyped.

Description:

Codeine and tramadol are opioid analgesics that depend on cytochrome P450 2D6 (CYP2D6) for bioactivation to morphine and O-desmethyltramadol, respectively. Morphine and O-desmethyltramadol have much greater affinity for the opioid receptor and thus are more powerful analgesics.

Individuals with genotypes associated with low CYP2D6 activity (poor metabolizers) are unable to convert sufficient amounts of codeine or tramadol to their active metabolites and may fail to derive sufficient pain relief. At the opposite extreme, individuals with genotypes associated with increased CYP2D6 activity (ultra-rapid metabolizers) are at risk for serious toxicity with usual codeine or tramadol doses.

The CYP2D6 genotype also has implications for response to other drugs, such as tricyclic antidepressants (TCAs), which are commonly used for neuropathic pain.

Patients will be recruited from family medicine clinics, serving as either implementation sites or control sites. Patients from implementation sites will undergo CYP2D6 genotyping, with results placed in the medical record to assist with prescribing of pain medications. Pain medications prescribed from baseline to 3 months will be assessed through medical record review. A pain assessment questionnaire will be administered to patients enrolled from both sites at baseline and 3 months.

At the end of the study, a 20-item survey will be administered to physicians at the implementation sites. We will assess whether having CYP2D6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective.

We will also assess medicines prescribed to patients enrolled from both sites over the 12-month period after enrollment from medical record review and determine the number of patients who were prescribed a medication that has genetic information in its FDA-approved label.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: October 25, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Treated in family medicine clinic

• History of pain for at least 3 months

• Prescribed medication for pain relief

Exclusion Criteria:

• Pain for less than 3 months

• Not currently prescribed any medication for pain

Related Conditions & MeSH terms

• Pain

Intervention

Genetic:
• CYP2D6 genotyping
CYP2D6 genotype results and an interpretive report will be placed in the electronic medical record to assist the physician with prescribing medication for pain management.

Other:
• Pain assessment questionnaire
A pain assessment questionnaire will be administered at baseline and 3 months.
• Physician assessment
20-item survey administered to physicians treating patients enrolled in the study

Locations

Country	Name	City	State
United States	Archer Family Health Care	Archer	Florida
United States	UF Health Family Medicine: Eastside	Gainesville	Florida
United States	UF Health Family Medicine: Haile Plantation	Gainesville	Florida
United States	UF Health Family Medicine: Hampton Oaks	Gainesville	Florida
United States	UF Health Family Medicine: Main Street	Gainesville	Florida
United States	UF Health Internal Medicine - Tower Hill	Gainesville	Florida
United States	UF Health Internal Medicine-Medical Plaza	Gainesville	Florida
United States	UF Health Spring Hill Pain Management	Gainesville	Florida
United States	UF Health Family Medicine - Old Town	Old Town	Florida
United States	Oviedo Family Health Center	Oviedo	Florida
United States	ProHealth Family Physicians	Saint Cloud	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Crews KR, Gaedigk A, Dunnenberger HM, Leeder JS, Klein TE, Caudle KE, Haidar CE, Shen DD, Callaghan JT, Sadhasivam S, Prows CA, Kharasch ED, Skaar TC; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium guidelines for cytochrome P450 2D6 genotype and codeine therapy: 2014 update. Clin Pharmacol Ther. 2014 Apr;95(4):376-82. doi: 10.1038/clpt.2013.254. Epub 2014 Jan 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)	Patient Reported Outcomes Measurement Information System (PROMIS) measures will be used to assess pain intensity, physical functioning, and emotional functioning. There are 10 subscales on the PROMIS questionnaire that address the domains of pain, pain functioning, and emotional functioning. At least 4 (and up to 30) items are used to derive a score for each subscale. A computer adaptive version of the questionnaire based on item response theory will be used to administer the survey. A score of 0 to 100 based on survey responses will be resulted for each subscale.	Change from baseline to 3 months
Secondary	Change in pain medication	Change in pain medication will be evaluated in several manners: change in the opiate prescribed, change from an opiate to a non-opiate; and change in dose of the opiate prescribed	Change from baseline to 3 months
Secondary	Change in pain score of pain intensity (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)	Patient Reported Outcomes Measurement Information System (PROMIS) subscale for pain intensity, with the score ranging from 0 to 100 resulting.	Change from baseline to 3 months
Secondary	Change in pain score of physical functioning (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)	Patient Reported Outcomes Measurement Information System (PROMIS) subscales for physical functioning include pain function, pain interference, pain behavior, sleep disturbance, and sleep-related impairment. A score of 0 to 100 based on survey responses will be resulted for each subscale.	Change from baseline to 3 months
Secondary	Change in pain score of emotional functioning	Patient Reported Outcomes Measurement Information System (PROMIS) subscales for emotional functioning include fatigue, anxiety, depression, and anger. A score of 0 to 100 based on survey responses will be resulted for each subscale.	Change from baseline to 3 months
Secondary	Physician perceived usefulness of genetic information (survey)	Survey will be administered to physicians with patients in the study to assess the effect of having genotype information on their prescribing decisions.	3 months
Secondary	Medications prescribed with pharmacogenetic implications (Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing)	Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing	12 months